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Gaining and Re-Establishing Control of Your Cleanroom
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
Why Should You Attend:
This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies on bringing up the site after a worst case event will be detailed. Excursion investigations and troubleshooting parameters and suggestions will also be discussed.
Areas Covered in the Webinar:
- The critical steps needed to release the room for manufacturing will be discussed.
- Routine cleaning and disinfection strategies will be covered as well as the latest in equipment and application.
- Establishing control of the cleanroom after a worst case event.
- Excursion events will be discussed and case studies will be covered regarding excursion events.
Who Will Benefit:
This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs, including companies in the pharmaceutical, biotech, and medical device fields. The employees who will benefit include:
- QA and QC managers
- Disinfectant validation managers
- Operations managers
- Cleanroom managers
- Personnel and contractors that clean and disinfect cleanrooms
- EH&S managers
- Regulatory compliance managers and environmental monitoring managers
Jim Polarin is a technical service manager at STERIS Corporation. He has been with STERIS Corporation for over eleven years, where his current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, Latin America, and Puerto Rico on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and has worked on several books and article publications related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is a co-author on the PDA technical report on cleaning and disinfection. He is also currently active on the PDA task force on cleaning and disinfection. He is part of the faculty at the University of Tennessee Parenteral Medication course. He has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee, SWE, and Barnett International on cleaning and disinfection and contamination control. Mr. Polarine also frequently presents global industry webinars on cleaning and disinfection including one that he co-presents with Carole Genovesi (Cleanroom Director at Genentech).
Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, ISPE, IEST, ASM, AALAS, ASTM, AAAS, AOAC, and ACS. He previously worked as a clinical research coordinator with the Department of Veteran’s Affairs and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and he is very active in tornado research and tornado safety.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms Validating Disinfectants for Pharmaceutical and Biotech Operations Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations Contamination Control 101 in Pharmaceutical, Biotech, and Medical Device Clean rooms